Design Assurance Engineer II

Location - Galway

2 Positions - 1 Permanent, 1 maternity contract

Force Recruitment have currently partnered with one of the top medical device manufacturing client who are on a look out for 2 device assurance engineer II for their site in Galway.

The individual in this position is responsible for leading and collaborating with cross-functional teams, including R&D, Regulatory Affairs, Process Development, Clinical Affairs, and Manufacturing Engineering.

Responsibilities:

• Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing Technical and Quality expertise to the team.
• Provides both quality and technical input to the stage gate design reviews, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
• Review/analyze whether current products and processes comply with standards such as ISO 13485 & EU MDR etc.
• Have experience in risk management, validation techniques, statistical techniques, and compliance with FDA/MDR regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
• Uses opportunities in project assignments to develop self & other team members. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer, and Design Assurance Technician.
• Build Quality into all aspects by maintaining compliance for all quality requirements. Participates in external audits including notified body.
• Provides design quality support in the resolution of product assessments, complaints investigation, CAPAs, regulatory requirement changes.
• Methodical review approach and capable of initiating and leading change through continuous improvement.

Education and Experience:

• A degree in Engineering, Technology, or Science.
• At least 3-5+ years’ experience working in a regulated medical device or pharmaceutical company.
• Excellent planning and coordination skills.
• Excellent verbal and written communication skills.
• Excellent attention to detail skills.
• Training in product risk management, problem solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous.

Skills and Competencies:

• Excellent understanding of ISO 14971 & 13485.
• Ability to work within a team environment to achieve agreed company goals.
• Ability to communicate quality / regulatory concepts effectively.
• Excellent understanding of ISO 13485 and FDA QS regulations.
• Understanding of Quality Systems.
• Understanding of Design Control Process.
• Proficiency in use of desktop software applications such as MS office, Word, Excel, PowerPoint.
• Some travel may be required with the role.